Beckman Coulter Inc. AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
All lot numbers.
Products Sold
All lot numbers.
Beckman Coulter Inc. is recalling AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 due to Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia.
Recommended Action
Per FDA guidance
On 12/08/2021, the firm sent recall notifications to customers via mail and e-mail. Customers with additional questions were encouraged to contact Customer Support: http://www.beckmancoulter.com or 1-800-223-0130 Action to be taken: "Retain a copy of this letter as it serves as current labeling. Where LIH influence check settings are enabled, customers must update the lipemia influence check settings on their AU/DxC AU analyzers. To determine if LIH influence check settings are enabled on your analyzer for Magnesium and to update your lipemia interference settings, perform the following action: DxC 700 AU: Select Menu List > Configuration Parameters > Specific Test Parameters > Test Volume and Methods > General > Edit. Update the LIH influence check for Magnesium Lipemia interference from +++++ to ++. AU480 / AU680 / AU5800: Select Menu > Parameters > Specific Test Parameters > General > Edit. Update the LIH influence check for Magnesium Lipemia interference from +++++ to ++. If LIH influence check settings are not enabled, review the new interference information in the IFU and assess whether changes are required to the reporting of magnesium results in the laboratory information system based on LIH flagging." Magnesium IFU (BAOSR6189) will be updated: The criteria for no significant interference is recovery within 10% or 0.29mg/dL (0.12mmol/L) of the initial value. Lipemia: No significant interference up to 200 mg/dL Intralipid The Magnesium setting sheet (BASOSR6189) will be updated so that the lipemia influence check setting is reduced from +++++ to ++. Please complete and return the response form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026